
Kallestad Laboratories, Inc.
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QUANTITOPE 125-I GENTAMICIN RIA KIT is an FDA 510(k)-cleared medical device (K780323) manufactured by Kallestad Laboratories, Inc.. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 16, 1978. Regulation: 8.